(260 days)
The V-Guide is designed to be used for frontal placement of an intraventricular catheter during a ventriculostomy. The device is for use with intraventricular catheters.
The V-Guide is a sterile, single use, Neurological Stereotactic Instrument that provides the surgeon with a localized reference guide for performing Ventriculostomies. The device is compatible with 3.3mm ventricular catheters. The device consists of a Base Assembly, three Impression Pins (16 Gauge Stainless Steel needles with aluminum hubs) that act as legs for the Base, a Pierce Sagittal assembly and a Pierce Barrel.
The device allows the user to orient the sagittal plane to 0° and the lateral plane to 0°. This aligns the device to a perpendicular track to the entry point. A standard 3.3mm catheter is then passed through the guide into the brain at the predetermined distance as in a standard Ventriculostomy. If the flow of cerebrospinal fluid is noted and the surgeon is satisfied the position of the catheter, the V-guide can be removed from the catheter by removing the barrel. If the surgeon is not satisfied with the position of the catheter, the catheter is removed and this technique can be repeated with different angles to allow for an objective change in direction of the catheters angle to the cranium.
The provided document describes the 510(k) summary for the Arc Surgicals Manufacturing LLC's V-Guide for Ventriculostomies (K141559), a neurological stereotaxic instrument designed for frontal placement of an intraventricular catheter. The document seeks to establish substantial equivalence to a legally marketed predicate device, the Sparta Instrument Corporation's Ghajar Intraventricular Catheter Guide (K854475).
Here's an analysis of the acceptance criteria and the study that proves the device meets the criteria, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (V-Guide) | Reported Device Performance (V-Guide) |
|---|---|
| Accuracy at 90° (Sagittal angle 0, Lateral Angle 0) | Accurate to ± 3.0mm with a target depth of 6 cm. |
| Comparison to Predicate Device (Ghajar Guide) | |
| Same technological characteristics | The V-Guide has "the same technological characteristics" as the Ghajar Guide in terms of guiding catheters for ventriculostomies, having 3 legs to position over the burr hole, placing catheters at 90° (perpendicular) to the skull (when set to 0 degrees), visual placement over the burr hole, hand-held during insertion, and being made of plastic material. |
| Differences: The V-Guide allows objective changes in catheter angle, while the Ghajar Guide is only indicated for 90-degree placement. The V-Guide is compatible with 3.3mm catheters, while the Ghajar Guide is 1.30-3.25mm. The V-Guide uses ABS with Stainless Steel Legs, while the Ghajar Guide uses plastic. Sterilization methods differ. | |
| Biocompatibility of Stainless Steel Legs | Established based on the use of a Covidien product (Monoject™ Standard Hypodermic Needle, Aluminum Hub, 16 G x 1") cleared under 510(k) K854547. |
| Performance comparable to predicate for safety and function | The non-clinical performance data "supports the safety of the device and the hardware verification demonstrate that the V-Guide device should perform as intended in the specified use conditions." The data demonstrate that the "V-Guide device performs comparably to the predicate device." |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated. The document mentions "a bench model" for accuracy testing, but does not provide details on the number of trials, measurements, or the total sample size used in this testing.
- Data Provenance: The study was a non-clinical bench test. There is no information regarding country of origin, retrospective, or prospective nature, as it was not a clinical study on human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The "ground truth" for the accuracy test was established by the physical setup of the bench model with a target at a known depth (6 cm) and the objective measurement of the V-Guide's placement accuracy. This is a technical measurement, not an expert-driven assessment.
- Qualifications of Experts: Not applicable for establishing ground truth in this context.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. The testing described is a technical performance assessment against a defined physical target, not an assessment requiring adjudication of human interpretations or classifications.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a physical stereotaxic instrument, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable in the context of an algorithm. This device is a physical instrument intended for use by a surgeon (human-in-the-loop) during a medical procedure. The "standalone" performance here refers to the instrument's accuracy as measured on a bench model, independent of a human surgeon's skill in operating it, other than to set it up for the test.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The ground truth for the accuracy testing was physical measurement against a known target. Specifically, the accuracy was measured in relation to a target at a 6 cm depth within the "bench model." The predicate device's performance was also tested against this same physical ground truth for comparison.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This document describes the testing of a medical device's physical performance, not the training of an AI algorithm.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there is no AI algorithm being trained.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).